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A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of People With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab

Information source: ImClone LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colon Cancer; Rectal Cancer

Intervention: Cetuximab (Biological); Irinotecan (Drug); IMC-A12 (cixutumumab) (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: ImClone LLC

Official(s) and/or principal investigator(s):
E-mail: ClinicalTrials@ ImClone.com, Study Director, Affiliation: ImClone LLC

Summary

The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in patients with metastatic colorectal cancer.

Clinical Details

Official title: A Randomized Phase II Clinical Trial Investigating Irinotecan Plus Cetuximab With or Without Anti-Insulin-Like Growth Factor-I Receptor Monoclonal Antibody (IMC-A12) for the Treatment of Patients With Metastatic K-Ras Wild Type Carcinoma of the Colon or Rectum That Has Progressed on Oxaliplatin and Bevacizumab Given as First-Line Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free Survival

Secondary outcome:

Objective Response Rate (ORR) (Complete Response plus Partial Response)

Overall Survival

Progression Free Survival (PFS) over entire duration

Resection Rate, the number of patients who had a complete resection/ablation of metastases with no evidence of disease remaining

Toxicity of the irinotecan + cetuximab + IMC-A12 regimen

Post-treatment serum levels of IMC-A12 in patients receiving IMC-A12

Change in Behavioral and Health Outcomes [BAHO] Quality of Life Questionnaire

Serum Anti-IMC-A12 Antibody Assessment

Detailed description: The purpose of this study is to determine the value of adding IMC-A12 to irinotecan + cetuximab in improving PFS at 18 weeks from the date of randomization for patients with metastatic K-RAS wild-type CRC that has progressed on an oxaliplatin/bevacizumab-containing regimen.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must consent to be in the study and must have signed and dated IRB-approved consent

forms conforming to federal and institutional guidelines for the pre-entry tumor sample submission for central K-RAS testing and for the study treatment

- Must have an ECOG performance status of 0, 1, or 2

- Must have metastatic CRC

- The CRC tumor or metastatic tumor must be K-RAS wild-type as determined by central

testing

- Must be documented disease progression during first-line therapy containing both

oxaliplatin and bevacizumab

- Most recent treatment regimen must have ended ≥ 21 days prior to randomization, and

clinically significant side effects associated with previous therapy must have resolved to ≤ grade 1 with the exception of neuropathy which must have resolved to ≤ grade 2

- Imaging of the chest, abdomen and pelvis with CT scan or MRI must be performed within

3 weeks prior to randomization

- Must have measurable disease, defined as at least one lesion outside a previous RT

field that can be accurately measured in at least one dimension as ≥ 20mm with conventional techniques or as ≥ 10mm with 5mm cuts using a spiral CT scan

- Evidence of adequate bone marrow function: ANC ≥ 1200/mm3, hemoglobin ≥ 9g/dL,

platelets ≥ 100,000/mm3

- Evidence of adequate hepatic function. If no liver metastases: AST ≤ 2. 5 x ULN, total

bilirubin ≤ 1. 5 x ULN for the lab. In the presence of liver metastases: AST ≤ 5. 0 x ULN, total bilirubin ≤ 1. 5 x ULN for the lab

- Serum creatinine must be ≤ 1. 5 x ULN for the lab

- Must have a fasting blood glucose < 126mg/dL. Fasting is defined as no caloric intake

for at least 8 hours Exclusion Criteria:

- Life expectancy less than 12 weeks

- Diagnosis of anal or small bowel carcinoma

- Tumor that is considered by the surgeon to be amenable to complete resection

- Previous radiation therapy to > 25% of bone marrow

- Radiation therapy to sites of measurable disease chosen as target lesions

- Radiological evidence and/or clinical signs or symptoms of CNS metastases

- Any of the following conditions and events: uncontrolled hypertension, defined as

systolic BP > 150mmHg or diastolic BP > 100 with or without antihypertensive medication (patients with hypertension that is well-controlled on medication are eligible); unstable angina within 6 months before randomization; NYHA Class III or IV cardiac disease; myocardial infarction within 6 months before randomization; symptomatic arrhythmia; CNS cerebrovascular ischemia (TIA or stroke) within 6 months before randomization

- Other malignancies unless the patient is considered to be disease-free and has

completed therapy for the malignancy ≥ 12 months prior to randomization. Patients with the following cancers are eligible if diagnosed and treated within the past 12 months: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin

- Serious or non-healing wound, skin ulcers, or bone fracture

- Any significant bleeding unless the source of bleeding has been resected

- History of bleeding diathesis or coagulopathy (patients on stable anticoagulant

therapy are eligible)

- Any evidence of active infection

- Active inflammatory bowel disease

- Grade 3 or 4 diabetes mellitus as defined by NCI's CTCAE v 3. 0 pancreatic endocrine:

glucose intolerance (patients with diabetes controlled with diet and/or oral medications are eligible)

- Symptomatic interstitial pneumonitis or definitive evidence of interstitial

pneumonitis described on CT scan or chest x-ray in asymptomatic patients

- Any other serious concomitant medical condition that, in the opinion of the

investigator, would compromise the safety of the patient or compromise the patient's ability to participate in the study

- Previous hypersensitivity reaction to monoclonal antibodies

- Previous treatment with irinotecan, cetuximab, or any agent specifically targeting

IGF receptors

- Treatment with an investigational drug within 30 days prior to randomization

- Pregnancy or lactation at the time of patient entry

- Psychiatric or addictive disorders or other conditions that, in the opinion of the

investigator, would preclude the patient from meeting the study requirements

Locations and Contacts

ImClone Investigational Site, Vallejo, California 94589, United States

ImClone Investigational Site, Greenville, North Carolina 27834, United States

ImClone Investigational Site, Scranton, Pennsylvania 18510, United States

Additional Information

Starting date: May 2009
Last updated: February 2, 2012

Page last updated: August 20, 2015

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